FDA 483 - AAA Pharmaceutical, Inc. - April 03, 2019

An FDA inspection of AAA Pharmaceutical, Inc. in Lumberton, NJ, a control testing laboratory and packager of OTC drugs, revealed significant deficiencies in their quality control unit's procedures and adherence to them. Observations included a lack of written procedures for critical operations like sampling and supplier monitoring, as well as a failure to properly review and approve changes to laboratory test methods. These issues indicate a systemic breakdown in maintaining adequate control over drug manufacturing processes.